Safety, Tolerability and Pharmacokinetic Investigation of GSK3882347 in Healthy Participants.
Status:
Completed
Trial end date:
2021-05-14
Target enrollment:
Participant gender:
Summary
This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled,
first time in human (FTIH) study, that includes both single-ascending and multiple-ascending
dose phase to assess the safety, tolerability, and pharmacokinetics (PK) of GSK3882347 in
healthy adult men and Woman of Non Childbearing Potential (WONCBP). Part 1 will be the single
ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each
participant in the SAD cohort will receive a single dose of GSK3882347 or placebo (PBO) in
3:1 ratio and in Part 2 (MAD), participants will be randomized in a 4:1 ratio to receive
active treatment and placebo. Part 1 will consist of two cohorts with a maximum of
four-period for each cohort, the food effect evaluation will be conducted in last period
(Period 4) in only one of the cohorts based on the observed human pharmacokinetics (PK). Part
2 will consist of maximum of four cohorts for each of the MAD dose or placebo.
Phase:
Phase 1
Details
Lead Sponsor:
GlaxoSmithKline
Collaborators:
Department of Health and Human Services Wellcome Trust